Design Solutions


Machine Builders – CE Marking Changes for non-EU Manufacturers

31 March 2021

There is no escaping the fact that the UK’s relationship with the European Union has changed since 1st January 2021. UK machine builders exporting to the European Economic Area (EEA) must continue to CE mark their machines to the Machinery Directive as they do now, but there is one vital change for which they must be ready: a person in the EEA must be named on the Declaration of Conformity (DoC) as authorised to compile the Technical File.

If the DoC still names somebody in the UK, then there is a risk that exported machines will be stopped at customs. And the same is true for UK-based manufacturers of partly completed machinery and safety components that fall within the scope of the Machinery Directive.

Larger companies that already have a subsidiary in the EU can simply change the DoC to show the name and address of a person in the EEA authorised to compile the Technical File, rather than someone in the UK.

Fortunately, there is a simple, expedient and cost-effective way to comply with the requirement to name a person in the EEA on the DoC – or, of course, the Declaration of Incorporation (DoI) for partly completed machinery. Hold Tech Files Ltd is established in Eire and can be named on a DoC or DoI as the person authorised to compile the Technical File. Note that the official ‘Guide to application of the Machinery Directive 2006/42/EC’ makes it clear that ‘The person authorised to compile the technical file is a natural or legal person’ – in other words, the ‘person’ named can, in fact, be a company.

EU Regulation 2019/1020 comes into force on 16th July 2021, at this point, there is a new requirement for anything supplied from outside the EU carrying CE Marking, to be supplied through an importer or fulfilment centre, who must hold the Technical Documentation, or there must be an EU Authorised Representative appointed to carry out these duties.

The Authorised Representative is responsible for ensuring the documentation is adequate and needs time to check it. Companies waiting until July may find they don’t have an EUAR in place which could cause delays on importing equipment into the EU.

Hold Tech Files Ltd has created a web-based service for manufacturers of machines, partly completed machines and safety components covered by the Machinery Directive. After signing a mandate and paying a fee (all fees are published on the website and there are no ‘hidden extras’), the relevant file can be uploaded and it is then backed up onto a separate server. Payment of a one-off fee entitles the manufacturer to name Hold Tech Files on the DoC or DoI for a period of ten years.

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